复方鼻舒喷雾剂的质量标准研究

Quality standard for compound Bishu spray

目的建立复方鼻舒喷雾剂的质量控制方法。方法采用薄层色谱法对制剂中的辛夷、白芷、牛蒡子进行定性鉴别;采用高效液相色谱法测定制剂中黄芩苷的含量。结果薄层色谱显色清晰且阴性对照无干扰。黄芩苷在2.28~37.32μg.mL-1与峰面积呈良好的线性关系（r=0.999 8）,平均回收率为99.51%,RSD=1.81%（n=6）。结论本法操作简便,结果准确、重复性好,可用于复方鼻舒喷雾剂的质量控制。

Objective To develop a quality control method for compound Bishu spray.Methods Flos Magnoliae,Radix Angelicae Dahuricae,and Fuctus Arctii were identified by thin-layer chromatoraphy.Baicalin was determined by HPLC.Results The chromatographic spots were identified without the interference of negative control.The linearity of baicalin was 2.28～37.32 μg·mL-1（r=0.999 8）.The average recovery was 99.51% with RSD=1.81%（n=6）.Conclusion This method is simple,accurate with good reproducibility,and can be used for the quality control of compound Bishu spray.